Topical ganciclovir has been available in Europe for the treatment of ocular viral infections for over 10 years. The product is currently marketed by Thea in Europe under the brand name of Virgan.
“Upon regulatory approval, ganciclovir gel would become the first topical ophthalmic anti-viral treatment launched in the US in over two decades. This product has the potential to advance the medical treatment of herpes simplex keratitis. Herpes simplex keratitis remains the leading cause of corneal blindness in the US,” said Dr Stephen Foster, president of Massachusetts Eye Research and Surgery Institute.
Under the agreement, Sirion will have the rights to manufacture, sell and distribute ganciclovir gel for ophthalmic use throughout the US and all US territories and possessions. Sirion will have access to the trade name Virgan for use in the territory.
Sirion said that it hopes to file a new drug application for ganciclovir ophthalmic gel with the FDA by the end of calendar year 2007.